Dry electrodes for electrophysiology measurements

ABSTRACT

Apparatuses for making electrical connections in electrophysiological measurements and monitoring are disclosed. One such apparatus includes a first side having an electrical contact; a second side opposing the first side and having an electrode disposed over the second side; and a layer disposed between the first side and the second side. The layer is adapted to remove moisture from a region around the electrode. The apparatus also has an electrode line in electrical contact with the electrode disposed over the layer on the first side and extending over the layer on the second side. The electrode line is electrically connected to the electrical contact.

BACKGROUND

In the field of electrophysiology, electrodes are used to connect ameasurement device with a biological body. These electrodes have anelectrode that makes contact with the skin of a body on one side, and asnap on the opposing side for making an electrical connection to aninstrument or measurement device used for electrophysiologicalmeasurements or monitoring, or both.

One known electrode is a hydrogel electrode. Hydrogel electrodes areused for various electrophysiological measurements, such aselectrocardiography (EKG) monitoring, connecting the patient to apatient monitor. Disposable hydrogel electrodes are also used forimpedance measurements (for respiratory activity and stress),electromyography for muscle activity measurements andelectroencephalography (EEG) for brain activity measurements.

Known dry electrodes require a small amount of moisture (e.g.,perspiration) in between the electrode and the skin for the electrode tofunction well. Unfortunately, too much moisture can build up between theelectrode and the skin, especially when the electrode is worn for longterm wear (e.g., three or more days). This excessive moisture can resultin poor connection of the electrode to the skin, an addition of anundesired insulating water-contacting layer, detachment of the electrodefrom the skin, and colorization of skin.

What is needed, therefore, is an apparatus for making contact to theskin for electrophysiological measurements and monitoring that at leastthe drawbacks of known electrodes described above.

SUMMARY

According to an aspect of the present disclosure, an apparatus formaking electrical connections in electrophysiological measurements andmonitoring is disclosed. The apparatus comprises: a first sidecomprising an electrical contact; a second side opposing the first sidecomprising an electrode disposed over the second side; and a layerdisposed between the first side and the second side. The layer isadapted to remove moisture from a region around the electrode. Theapparatus further comprises an electrode line in electrical contact withthe electrode disposed over the layer on the first side and extendingover the layer on the second side, wherein the electrode line iselectrically connected to the electrical contact.

According to another aspect of the present disclosure, an apparatus formaking electrical connections in electrophysiological measurements andmonitoring is described. The apparatus comprises: a first sidecomprising an electrical contact; and a second side opposing the firstside comprising an electrode disposed over the second side. Theelectrode comprises a groove adapted to remove moisture from a regionaround the electrode.

According to another aspect of the present disclosure, an apparatus formaking electrical connections in electrophysiological measurements andmonitoring is disclosed. The apparatus comprises: a first sidecomprising an electrical contact; a second side opposing the first sidecomprising an electrode disposed over the second side; a layercomprising a gap and being disposed between the first side and thesecond side, wherein the gap is adapted to remove moisture from a regionbeneath the electrical contact; and a plurality of electricallyconductive spokes extending radially from an outer boundary of theelectrical contact.

BRIEF DESCRIPTION OF THE DRAWINGS

The example embodiments are best understood from the following detaileddescription when read with the accompanying drawing figures. It isemphasized that the various features are not necessarily drawn to scale.In fact, the dimensions may be arbitrarily increased or decreased forclarity of discussion. Wherever applicable and practical, like referencenumerals refer to like elements.

FIG. 1A is a cross-sectional view of an apparatus for making electricalconnections in electrophysiological measurements and monitoringaccording to a representative embodiment.

FIG. 1B is top view of an electrode structure for use in an apparatusfor making electrical connections in electrophysiological measurementsand monitoring according to a representative embodiment.

FIG. 1C is top view of an apparatus for making electrical connections inelectrophysiological measurements and monitoring according to arepresentative embodiment.

FIGS. 2A-2D are top views of electrode structures for use in apparatusesfor making electrical connections in electrophysiological measurementsand monitoring according to a representative embodiment.

FIGS. 3A-3C are top views of electrodes, electrical contacts, electrodelines and layers adapted to remove moisture from a region around theelectrode according to various representative embodiments.

FIGS. 4A-4B are top views of electrodes for use in apparatuses formaking electrical connections in electrophysiological measurements andmonitoring according to a representative embodiment.

FIG. 5A is a top view of an electrode and an adhesive layer for use inapparatuses for making electrical connections in electrophysiologicalmeasurements and monitoring according to a representative embodiment.

FIG. 5B is an enlarged view of a portion of the electrode and adhesivelayer of FIG. 5A.

FIG. 6A is a cross-sectional view of an apparatus for making electricalconnections in electrophysiological measurements and monitoringaccording to a representative embodiment.

FIG. 6B is top view of an electrode for use in an apparatus for makingelectrical connections in electrophysiological measurements andmonitoring according to a representative embodiment.

DETAILED DESCRIPTION

In the following detailed description, for the purposes of explanationand not limitation, representative embodiments disclosing specificdetails are set forth in order to provide a thorough understanding of anembodiment according to the present teachings. Descriptions of knownsystems, devices, materials, methods of operation and methods ofmanufacture may be omitted so as to avoid obscuring the description ofthe representative embodiments. Nonetheless, systems, devices andmethods that are within the purview of one of ordinary skill in the artare within the scope of the present teachings and may be used inaccordance with the representative embodiments. It is to be understoodthat the terminology used herein is for purposes of describingparticular embodiments only and is not intended to be limiting. Thedefined terms are in addition to the technical and scientific meaningsof the defined terms as commonly understood and accepted in thetechnical field of the present teachings.

It will be understood that, although the terms first, second, third,etc. may be used herein to describe various elements or components,these elements or components should not be limited by these terms. Theseterms are only used to distinguish one element or component from anotherelement or component. Thus, a first element or component discussed belowcould be termed a second element or component without departing from theteachings of the inventive concept.

The terminology used herein is for purposes of describing particularembodiments only and is not intended to be limiting. As used in thespecification and appended claims, the singular forms of terms “a,” “an”and “the” are intended to include both singular and plural forms, unlessthe context clearly dictates otherwise. Additionally, the terms“comprises,” “comprising,” and/or similar terms specify the presence ofstated features, elements, and/or components, but do not preclude thepresence or addition of one or more other features, elements,components, and/or groups thereof. As used herein, the term “and/or”includes any and all combinations of one or more of the associatedlisted items.

Unless otherwise noted, when an element or component is said to be“connected to,” “coupled to,” or “adjacent to” another element orcomponent, it will be understood that the element or component can bedirectly connected or coupled to the other element or component, orintervening elements or components may be present. That is, these andsimilar terms encompass cases where one or more intermediate elements orcomponents may be employed to connect two elements or components.However, when an element or component is said to be “directly connected”to another element or component, this encompasses only cases where thetwo elements or components are connected to each other without anyintermediate or intervening elements or components.

By the present teachings, among other things, apparatuses for makingelectrical connections in electrophysiological measurements andmonitoring are disclosed. As described more fully below, in certainembodiments a layer is provided between the electrical contact and theelectrode. In other embodiments, a groove is provided in the electrode.In yet other embodiments, a layer comprising a gap and is disposedbetween the first side and the second side of the apparatus, and aplurality of electrically conductive spokes extend radially from anouter boundary of the electrical contact. Among other benefits andimprovements to the technical field, the various representativeembodiments provide various ways to remove moisture between theelectrode adapted to contact the surface (e.g., skin) of a body. Thisremoval of moisture improves not only the electrical connections betweenthe measurement or monitor devices, but also improves the duration ofthe adhesion of the apparatus to the body and prevents irritation of thebody at the location of the electrode to the skin.

Turning to FIG. 1A, a cross-sectional view of an apparatus 100 formaking electrical connections in electrophysiological measurements andmonitoring is disclosed. The apparatus 100 comprises a first side 101comprising an electrical contact 102 having a contacting portion; asecond side 103 opposing the first side 101 and comprising an electrode104 disposed over the second side 103. A layer 106 is disposed betweenthe first side 101 and the second side 103 which makes contact with thebody (e.g., the skin of the body). As described more fully below, thelayer 106 is adapted to remove moisture from a region around theelectrode 104 where the electrode 104 contacts the body.

The apparatus 100 further comprises an electrode lead line 108 disposedover the layer 106 on the second side 103 and extending over the layer106 on the first side 101 and provides an electrical connection betweenthe electrode 104 and the electrical contact 102 at an opposingelectrical contact 109 via a contacting portion 110 of the electricalcontact 102. Notably, the electrode lead line 108 (and similar leadlines described herein) may comprise a single layer of electricalconductive material directly applied (e.g., printed) on layer 106, ormay comprise a “free-standing” a layer of electrical conductive materialdisposed on a substrate. Finally, the apparatus 100 comprises anadhesive layer 112 that affixes the apparatus to the body. Notably,adhesive layer 112 also comprises a backing layer (not shown) facing thefirst side 101 (i.e., the side opposing the side of adhesive layer 112opposing the adhesive layer). The backing layer may comprise foil, foam,paper, woven knitted textiles, or non-woven knitted textiles.

In operation, the apparatus 100 is adhered to the body by the adhesivelayer 112 with the electrode 104 making physical contact to the body.The electrode lead line 108 provides an electrical connection betweenthe electrode 104 and the electrical contact 102, which isillustratively a snap contact that connects to lead from a measurementor monitoring device (not shown).

The layer 106 is not substantially electrically conductive, butsubstantially electrically insulative, and is selected for its abilityits remove moisture in the region where the electrode 104 contacts thebody at the second side. Illustratively, layer 106 has a resistance thatis greater than that of human skin (i.e., greater than 0.1M Ω to 1.0MΩ). Notably, while the layer 106 could be electrically conductive, thematerials selected for this layer are selected for their moistureremoval properties. Many if not all of such materials are notelectrically conductive. Generally, the layer 106 comprises a porousbiocompatible material that can absorb and/or transport moisture in theregion where the electrode 104 makes contact with the body converts andtransports the bio-signals (as e.g. EKG) to the electrode lead line 108,but releases the moisture to the ambient. Beneficially, the layer 106 isa breathable that transports humidity and gases/air and thus wicksmoisture from the region where the electrode 104 makes contact with thebody and substantially reduces or prevents collection of moisture in theregion where the electrode 104 makes contact with the body (i.e.,between the electrode 104 and the body). In certain representativeembodiments, the layer 106 comprises an open cell foam material that isbreathable and beneficially exhibits moisture removal from the regionwhere the electrode makes contact with the body. Notably, open cell foamis a synthetic foam in which all air pockets are not completely enclosedand have a ‘cobweb’ or ‘lattice’ structure appearance. The open cellfoam contemplated for use as the layer 106 is soft and flexible comparedto known materials used in wound care. Selected open cell foam materialscontemplated for use as the layer 106 allow water/sweat to flow betweenthe air pockets, and ultimately and beneficially out of the region wherethe electrode 104 makes contact with the body. The layer 106 having anopen cell foam structure has a thickness that is great enough to allowmoisture to pass through it (as opposed to tape, which does not).

Illustratively, open cell foam from Yulex® Incorporated of Chandler,Ariz. USA, such as Yulex® OC foam, may be used for the layer 106.

FIG. 1B is top view of an electrode structure 120 for use in theapparatus 100 for making electrical connections in electrophysiologicalmeasurements and monitoring according to a representative embodiment.Various aspects and details of the presently described representativeembodiments are common to those described above in connection with FIG.1A, and may not be repeated to avoid obscuring the presently describedrepresentative embodiments. The electrode structure 120 comprises theelectrode 104, the opposing electrical contact 109, and the electrodelead line 108 disposed therebetween. The electrode structure 120 maycomprise a known biocompatible electrically conductive material used inmedical applications. By way of illustration, the biocompatibleelectrically conductive material used for the electrode structure 120may be as described in U.S. Pat. Nos. 8,792,957, 10,726,967, and U.S.patent application Publication No.

As shown more clearly in FIG. 1A, the electrode lead line 108 isdisposed (e.g., folded) around the layer 106 and provides an electricalpath between the electrode 104 and the electrical contact 102 via theopposing electrical contact 109.

Notably, the electrode structure 120 may be an integral unit as shownformed from a piece of suitably electrically conductive material.Alternatively, the electrode 104 may be connected to the opposingelectrical contact 109 via an electrically conductive line printed onthe layer 106 and between the electrode 104 and the opposing electricalcontact. Illustratively, the printed electrically conductive line maycomprise a layer of silver chloride (AgCl) over a layer of silverdisposed over the layer 106 using one of a variety of known techniques.

FIG. 1C is top view of apparatus 100 for making electrical connectionsin electrophysiological measurements and monitoring according to arepresentative embodiment. Notably, FIG. 1C depicts the apparatus 100from the second side 103, which is the side of the apparatus that makescontact with the body. Various aspects and details of the presentlydescribed representative embodiments are common to those described abovein connection with FIGS. 1A-1B, and may not be repeated to avoidobscuring the presently described representative embodiments.

As shown, the apparatus 100 comprises the electrode 104 that makescontact with the body, and the adhesive layer 112 that provides theadhesion of the apparatus 100 to the body. Also shown are the portion oflayer 106 that extends past an edge 122 of the electrode 104, and theelectrode lead line 108 that is folded or otherwise disposed over theside of layer 106 and provides the electrical connection between theelectrode 104 and the electrical contact 102 (not shown in FIG. 1C) ofthe apparatus. As noted above, the layer 106 wicks moisture from theregion where the electrode 104 makes contact with the body and past theedge 122 of the electrode 104 for removal into the ambient. This actionby the layer substantially reduces or prevents collection of moisture inthe region where the electrode 104 makes contact with the body (i.e.,between the electrode 104 and the body). Again, in certainrepresentative embodiments, the layer 106 comprises an open cell foammaterial that is breathable and beneficially exhibits moisture removalfrom the region where the electrode 104 makes contact with the body.

FIGS. 2A-2D are top views of electrode structures 220 for use inapparatuses for making electrical connections in electrophysiologicalmeasurements and monitoring according to a representative embodiment.Various aspects and details of the presently described representativeembodiments are common to those described above in connection with FIGS.1A-1C, and may not be repeated to avoid obscuring the presentlydescribed representative embodiments. Notably, the electrode structures220 comprise an electrically conductive material as noted above, andhave the layer 106 (not shown in FIGS. 2A-2D) and the adhesive layer 112(not shown in FIGS. 2A-2D) disposed thereover. As such, the electrodestructures 220 are similar to the electrode structure 120 described inconnection with FIGS. 1B-1C with modifications discussed presently.

Improving the surface area of contact between the layer 106 and the bodyto which the apparatus 100 is attached beneficially increases theability of the layer 106 to remove moisture from the region where theelectrode makes contact with the body. FIGS. 2A-2D depict illustrativeelectrode structures 220 each comprising an electrode 204, and anelectrical line 208 making an electrical connection between theelectrode 204 and the opposing electrical contact 209. However, theelectrodes 204 of the electrode structures 220 of FIGS. 2A-2D haveportions removed as shown. As will be appreciated, when electrodestructures 220 are substituted from electrode structure 120 in thestructure such as depicted in FIG. 1A, the portions of the electrodes204 that are removed have corresponding portions of the layer 106exposed. By reducing the area of the layer 106 that is covered by theelectrodes 204, removal of moisture in the region where the electrode204 makes contact with the body is improved. While the area of contactfor making measurements is reduced with the removal of portions of theelectrode 204, the improvement in wearability is beneficial. Statedsomewhat differently, layer 106 wicks away moisture via its heighttowards the outside where this layer 106 is not covered by thecontacting portion 110. The grooves of the presently describedembodiments enable more efficient transportation of moisture (sweat) byproviding a more direct path (moisture does not need to pass through theelectrode 104), and by providing a capillary effect to create a channeleffect pulling moisture away from the center of the electrode 204.Notably, the grooves may comprise a venus valve.

Specifically, as described above, removal of moisture in the regionwhere the electrodes 104, 204 beneficially results in better adhesion ofthe electrode 104, 204, reduces skin irritation from prolonged wear, andresults in better performance of the electrodes 104,204. Furthermore,the various openings in the electrode structure discussed below, fosterimproved mobility of the electrodes 104, 204. Specifically, theelectrodes 104, 204 are elastic and follow the movements of the skin. Byremoving portions of the electrode such as the grooves and openings ofelectrode 204 described below, the electrode 204 is more pliable thanelectrode 104 described above. This increase in pliability allows theelectrode 204 to move more freely with movement of the anatomical partof the body to which it is attached, resulting in a more comfortableconnection with a reduction in its becoming unattached from the body.So, in addition to providing an improvement in moisture removal, thegrooves and openings described below further improve the long-termperformance of the electrode structures of various representativeembodiments.

FIG. 2A shows a top view of the electrode structures 220 comprising theelectrode 204, and the electrical line 208 making an electricalconnection between the electrode 204 and an opposing electrical contact209. In the electrode structure 220 of FIG. 2A, a central portion 224and grooves 226 extending therefrom are formed by removal of theelectrode 204 (or just not forming the electrode 204 in the centralportion 224 and grooves 226) as shown. In the electrode structure 220 ofFIG. 2A, with the central portion 224 and the grooves 226, whensubstituted for electrode 104 in the apparatus 100 described above,expose more surface area of the layer 106 to the ambient, therebyfostering improved removal of moisture from the region where theelectrode 204 makes contact with the body. Furthermore, in addition toexposing the layer 106 (not shown in FIG. 2A), the grooves 226 alsoprovide paths for the moisture to be removed from an edge 222 of theelectrode 204. As such, the grooves provide a capillary action, whichresults in further removal of moisture from the region where theelectrode 204 makes contact with the body.

FIG. 2B shows a top view of the electrode structure 220 comprising theelectrode 204, and the electrical line 208 making an electricalconnection between the electrode 204 and the opposing electrical contact209. In the electrode structure 220 of FIG. 2B, a openings 230 areprovided in the electrode 204 and thereby, when substituted forelectrode 104 in the apparatus 100 described above, exposes more surfacearea of the layer 106 to the ambient, thereby fostering improved removalof moisture from the region where the electrode 204 makes contact withthe body.

FIG. 2C shows a top view of the electrode structures 220 comprising theelectrode 204 and the electrical line 208 making an electricalconnection between the electrode 204 and the opposing electrical contact209. In the electrode structure 220 of FIG. 2C, grooves 240 extend fromthe center of the electrode 204 by removal of the electrode 204 (or justnot forming the electrode 204 where grooves 226 are provided) as shown.In the electrode structure 220 of FIG. 2C, with the grooves 226, whensubstituted for electrode 104 in the apparatus 100 described above, moresurface area of the layer 106 is exposed to the ambient, therebyfostering improved removal of moisture from the region where theelectrode 204 makes contact with the body. Furthermore, in addition toexposing the layer 106 (not shown in FIG. 2C), the grooves 240 providepaths for the moisture to be removed toward the edge 222 of theelectrode 204. This improves further removal of moisture from the regionwhere the electrode 204 makes contact with the body.

FIG. 2D shows a top view of the electrode structure 220 comprising theelectrode 204, and the electrical line 208 making an electricalconnection between the electrode 204 and the opposing electrical contact209. In the electrode structure 220 of FIG. 2D, a central portion 250and a surrounding portion 252 are provided in the electrode 204 byremoving or not forming the electrode 204 in these areas. Whensubstituted for electrode 104 in the apparatus 100 described above, moresurface area of the layer 106 is exposed to the ambient, therebyfostering improved removal of moisture from the region where theelectrode 204 makes contact with the body.

FIGS. 3A-3C are top views of electrodes, electrical contacts, electrodelines, and layers adapted to remove moisture from a region around theelectrode according to various representative embodiments. Variousaspects and details of the presently described representativeembodiments are common to those described above in connection with FIGS.1A-2D, and may not be repeated to avoid obscuring the presentlydescribed representative embodiments.

Turning to top part of FIG. 3A an electrode structure 320 is shown, andcomprises an electrode 304 and an opposing electrical contact 309connected to the electrode 304 by an electrical lead line. As will beappreciated, the electrode 304 is disposed on the second side and is incontact with the body, whereas the opposing electrical contact 309 is onthe first side and makes electrical contact with the electrical contact102 shown in FIG. 1 . As will be appreciated, the electrode structure320 is substantively the same as electrode structure 120 discussed abovein connection with FIG. 1B.

In the middle part, FIG. 3A also shows a portion of layer 306 thatextends past an edge 322 of the electrode 304, and the electrode leadline 308 that is folded or otherwise disposed over the side of layer 106and provides the electrical connection between the electrode 304 and theelectrical contact 102 (not shown in FIG. 3A) of the apparatus. Statedsomewhat differently, if substituted for the electrode structure 120 ofFIG. 1B, this part of FIG. 3A would be on the second side 103 of theapparatus 100. As noted above, the layer 306 wicks moisture from theregion where the electrode 304 makes contact with the body and past theedge 322 of the electrode 304 for removal into the ambient.

Finally, in the lower part FIG. 3A shows the layer 306 with the opposingelectrical contact 309 and electrode lead line 308. If substituted forthe electrode structure 120 of FIG. 1B, this part of FIG. 3A would be onthe first side 101 of the apparatus 100, with the opposing electrodemaking contact with electrical contact 102.

Turning to top part of FIG. 3B an electrode structure 320 is shown, andcomprises electrodes 304 and an opposing electrical contact 309connected to each of the electrodes 304 by respective electrode leadlines 308. As will be appreciated, the electrodes 304 are disposed onthe second side and are in contact with the body, whereas the opposingelectrical contact 309 is on the first side and makes electrical contactwith the electrical contact 102 shown in FIG. 1 .

In the middle part, FIG. 3B also shows layer 306 with the electrodes304, and the electrode lead lines 308 that are folded or otherwisedisposed over the side of layer 306 and provides the electricalconnection between the respective electrodes 304 and the electricalcontact 102 (see FIG. 1A—not shown in FIG. 3B) of the apparatus. Statedsomewhat differently, if substituted for the electrode structure 120 ofFIG. 1B, this part of FIG. 3B would be on the second side 103 of theapparatus 100. As noted above, the layer 306 wicks moisture from theregion where the electrodes 304 makes contact with the body and past theedge 322 of the electrode 304 for removal into the ambient. Notably,however, compared to the representative embodiment of FIG. 3A, a greatersurface area of the layer 306 is exposed and thus is in contact with theskin and fosters more efficient removal of moisture from the regionwhere the electrodes 304 make contact with the body. While the area ofcontact for making measurements is reduced using electrodes 304 in FIG.3B, the improvement in wearability is beneficial. Specifically, asdescribed above, removal of moisture in the region where the electrodes304 beneficially results in better adhesion of the electrodes 304 andreduces skin irritation from prolonged wear.

Finally, in the lower part FIG. 3B shows the layer 306 with the opposingelectrical contact 309 and electrode lead lines 308 that connect theopposing electrical contact 309 to electrodes 304. If substituted forthe electrode structure 120 of FIG. 1B, this part of FIG. 3B would be onthe first side 101 of the apparatus 100, with the opposing electrodemaking contact with electrical contact 102. Furthermore, compared to thestructure of FIG. 3A, in the electrode structure 320 of FIG. 3B thesurface area of the electrodes 304 is reduced. Like the grooves andopenings described above in connection with FIGS. 2A-2D, this reductionin contact area of the electrodes 304 with the body not only increasesthe exposed surface area of the layer 306, but also fosters improvedmobility of the electrode structure 320 on side that contacts the body.Specifically, the electrodes 304 are elastic and follow the movements ofthe skin. By providing a comparative reduction in the area of connectionof the electrodes 304 (compared to the electrode 304 of FIG. 3A orelectrode 104 of FIG. 1B), the electrode structure 320 is more pliable.This increase in pliability allows the electrode 304 to move more freelywith movement of the anatomical part of the body to which it isattached, resulting in a more comfortable connection with a reduction inits becoming unattached from the body. So, in addition to providing animprovement in moisture removal, the grooves and openings describedbelow further improve the long-term performance of the electrodestructures of various representative embodiments.

Turning to top part of FIG. 3C an electrode structure 320 is shown, andcomprises electrodes 304 and an opposing electrical contact 309connected to each of the electrodes 304 by respective electrode leadlines 308. As will be appreciated, the electrodes 304 are disposed onthe second side and are in contact with the body, whereas the opposingelectrical contact 309 is on the first side and makes electrical contactwith the electrical contact 102 shown in FIG. 1 .

In the middle part, FIG. 3C shows layer 306 with the electrodes 304, andthe electrode lead lines 308 that are folded or otherwise disposed overthe side of layer 306 and provide the electrical connection between therespective electrodes 304 and the electrical contact 102 (see FIG.1A—not shown in FIG. 3C) of the apparatus. Stated somewhat differently,if substituted for the electrode structure 120 of FIG. 1B, this part ofFIG. 3C would be on the second side 103 of the apparatus 100. As notedabove, the layer 306 wicks moisture from the region where the electrodes304 makes contact with the body and past the edge 322 of the electrode304 for removal into the ambient. Notably, however, compared to therepresentative embodiment of FIG. 3A, a greater surface area of thelayer 306 is exposed and thus is in contact with the skin, and fostersmore efficient removal of moisture from the region where the electrodes304 make contact with the body. While the area of contact for makingmeasurements is reduced using electrodes 304 in FIG. 3C, the improvementin wearability is beneficial. Specifically, as described above, removalof moisture in the region where the electrodes 304 beneficially resultsin better adhesion of the electrodes 304 and reduces skin irritationfrom prolonged wear.

Finally, in the lower part FIG. 3B shows the layer 306 with the opposingelectrical contact 309 and electrode lead lines 308 that connect theopposing electrical contact 309 to electrodes 304. If substituted forthe electrode structure 120 of FIG. 1B, this part of FIG. 3B would be onthe first side 101 of the apparatus 100, with the opposing electrodemaking contact with electrical contact 102. Furthermore, compared to thestructure of FIG. 3A, in the electrode structure 320 of FIG. 3C, thesurface area of the electrodes 304 is reduced. Like the grooves andopenings described above in connection with FIGS. 2A-2D, this reductionin contact area of the electrodes 304 with the body not only increasesthe exposed surface area of the layer 306, but also fosters improvedmobility of the electrode structure 320 on side that contacts the body.Specifically, the electrodes 304 are elastic and follow the movements ofthe skin. By providing a comparative reduction in the area of connectionof the electrodes 304 (compared to the electrode 304 of FIG. 3A orelectrode 104 of FIG. 1B), the electrode structure 320 is more pliable.This increase in pliability allows the electrode 304 to move more freelywith movement of the anatomical part of the body to which it isattached, resulting in a more comfortable connection with a reduction inits becoming unattached from the body. So, in addition to providing animprovement in moisture removal, the grooves and openings describedbelow further improve the long-term performance of the electrodestructures of various representative embodiments.

FIGS. 4A-4B are top views of electrodes for use in apparatuses formaking electrical connections in electrophysiological measurements andmonitoring according to a representative embodiment. Various aspects anddetails of the presently described representative embodiments are commonto those described above in connection with FIGS. 1A-3C, and may not berepeated to avoid obscuring the presently described representativeembodiments.

Turning to FIG. 4A, a top view of an electrode 404 is shown. Theelectrode 404 has grooves 426 extending from a central portion 424. Asnoted above, the grooves are formed by removal of portions of theelectrode 404 (or just not forming the electrode 404 in the regionswhere the grooves 426 are provided) as shown.

The electrode 404 differs from the previously described electrodestructures (e.g., electrode structure 220) at least because no layer(e.g. layer 106) is provided over the electrode 404. Rather, the grooves426 provide paths for the moisture to be removed toward the edge 422 ofthe electrode 404. As such, the grooves 426 provide a capillary action,which results in removal of moisture from the region where the electrode204 makes contact with the body. Notably, the electrode 404 may havegrooves/openings such as shown in and described in connection with therepresentative embodiments of FIGS. 2A-2D.

Another difference between the electrode 404 and the previouslydescribed electrode structure is the absence of an electrical line(e.g., electrode lead line 108) and opposing electrical contact (e.g.,opposing electrical contact 109). To this end, because a layer (e.g.,layer 106) is not used in this representative embodiment, the electricalpath that connects the electrode (e.g., 204) to the electrical contact(e.g., electrical contact 102) is not needed. Rather, as described morefully below in connection with FIGS. 5A and 5B, the electrode 404 makesdirect contact with the electrical contact to which leads are attachedto connect the electrode 404 to the measurement or monitoring device.When substituted for electrode 104 in the apparatus 100 described above,and foregoing the layer 106, electrode lead line 108 and opposingelectrical contact 109, moisture is removed by the grooves 426 from thecentral portion 424 towards the edge 422, thereby fostering improvedremoval of moisture from the region where the electrode 404 makescontact with the body.

Turning to FIG. 4B, a top view of electrode 404 is shown. The electrode404 has grooves 426 extending from the central portion 424. As notedabove, the grooves are formed by removal of portions of the electrode404 (or just not forming the electrode 404 in the regions where thegrooves 426 are provided) as shown.

The electrode 404 differs from the previously described electrodestructures (e.g., electrode structure 220) at least because no layer(e.g. layer 206) is provided over the electrode 404. Rather, the grooves426 provide paths for the moisture to be removed toward the edge 422 ofthe electrode 404. As such, the grooves 426 provide a capillary action,which results in removal of moisture from the region where the electrode204 makes contact with the body.

Another difference between the electrode 404 and the previouslydescribed electrode structures is the absence of an electrical line(e.g., electrode lead line 108) and opposing electrical contact (e.g.,opposing electrical contact 109). To this end, because a layer (e.g.,layer 106) is not used in this representative embodiment, the electricalpath (e.g., electrode lead line 108) that connects the electrode (e.g.,204) to the electrical contact (e.g., electrical contact 102) is notneeded. Rather, as described more fully below in connection with FIGS.5A and 5B, the electrode 404 makes direct contact with the electricalcontact (e.g., electrical contact 102) to which leads are attached toconnect the electrode 404 to the measurement or monitoring device. Whensubstituted for electrode 104 in the apparatus 100 described above, andforegoing the layer 106, electrode lead line 108 and opposing electricalcontact 109, moisture is removed by the grooves from the central portion424 towards the edge 422 allowing the moisture to evaporate more easily,thereby fostering improved removal of moisture from the region where theelectrode 404 makes contact with the body.

FIG. 5A is a top view of an electrode 504 and an adhesive layer 512 foruse in apparatuses for making electrical connections inelectrophysiological measurements and monitoring according to arepresentative embodiment. FIG. 5B is an enlarged view of a portion ofthe electrode and adhesive layer of FIG. 5A. Various aspects and detailsof the presently described representative embodiments are common tothose described above in connection with FIGS. 1A-4B, and may not berepeated to avoid obscuring the presently described representativeembodiments.

Turning to FIG. 5A, the top view of the electrode 504 shows the secondside which contacts the skin of the body, and is electrically connectedto the electrical contact on the opposing side (e.g., electrical contact102 on first side 101—not shown in FIG. 5A).

The electrode 504 has grooves 526 extending from the central portion524. As noted above, the grooves 526 are formed by removal of portionsof the electrode 504 (or just not forming the electrode 504 in theregions where the grooves 526 are provided) as shown.

The electrode 504 differs from the previously described electrodestructures (e.g., electrode structure 220) at least because no layer(e.g. layer 206) is provided over the electrode 404. Rather, the grooves526 provide paths for the moisture to be removed toward the edge 522 ofthe electrode 504. As such, the grooves 526 provide a capillary action,which results in removal of moisture from the region where the electrode504 makes contact with the body allowing the moisture to evaporate moreeasily.

Another difference between the electrode 504 and the previouslydescribed electrode structures is the absence of an electrical line(e.g., electrode lead line 108) and opposing electrical contact (e.g.,opposing electrical contact 109). To this end, because a layer (e.g.,layer 106) is not used in this representative embodiment, the electricalpath (e.g., electrode lead line 108) that connects the electrode (e.g.,104) to the electrical contact (e.g., electrical contact 102) is notneeded. Rather, the electrode 504 makes direct contact with theelectrical contact, to which leads are attached to connect the electrode504 to the measurement or monitoring device, via contacting portion(e.g., the electrical connection is made to the electrical contact 102via the contacting portion 110).

When substituted for electrode 104 in the apparatus 100 described above,and foregoing the layer 106, electrode lead line 108 and opposingelectrical contact 109, moisture is removed by the grooves from thecentral portion 524 and contacting portion (e.g., contacting portion 110(not shown in FIG. 5A)) on the opposing side (outlined by dotted line510) towards the edge 522, thereby fostering improved removal ofmoisture from the region where the electrode 504 makes contact with thebody. This is shown more clearly in FIG. 5B. Notably that the moistureonly must be transported away from the area where the electrode 504overlaps the contacting portion. As such, outside the circle formed bythe dotted line 510 (and thus outside the contacting portion), theadhesive layer 512 and supporting structure (e.g., a non-woven fabric orfoam) the material can breathe, transporting moisture through thelayers.

FIG. 6A is a cross-sectional view of an apparatus 600 for makingelectrical connections in electrophysiological measurements andmonitoring according to a representative embodiment. Various aspects anddetails of the presently described representative embodiments are commonto those described above in connection with FIGS. 1A-5B, and may not berepeated to avoid obscuring the presently described representativeembodiments.

Turning to FIG. 6A, a cross-sectional view of an apparatus 600 formaking electrical connections in electrophysiological measurements andmonitoring is disclosed. The apparatus 100 comprises a first side 601comprising an electrical contact 602 having a contacting portion 610;and a second side 603 opposing the first side 601 and comprising anelectrode 604. A layer 606 is disposed between the first side 601 andthe second side 603, which makes contact with the body (e.g., the skinof the body). The layer 606 may be a non-woven material or foam isadapted to remove moisture from a region around the contacting portion610 where the contacting portion 610 contacts the body. Notably,contacting portion 610 is ring-shaped with an opening in its center.

The apparatus 600 further comprises electrode lead lines 608 (see FIG.6B), in the shape of spokes and extending over the layer 606 on thefirst side 601. The electrode lead lines 608 provide an electricalconnection between the electrode 604 and the electrical contact 602.

The apparatus 600 further comprises an adhesion layer 642 disposed overan optional foam layer 644 and a conductor 646, which is illustrativelyprinted. The contacting portion 610, which as noted above isring-shaped, makes electrical contact to the conductor 646 at the centerof the electrical contact 602 to ensure electrical contact to theelectrode lead lines 608 (spokes). It is beneficial for the contactingportion 610 to make good contact with the conductor 646 to ensure properconduction of electrical signals (e.g., ECG signals) to the snap. In onerepresentative embodiment, the contacting portion 610 has an outergeometry (e.g., diameter) that is less than or equal to the outergeometry (e.g., diameter) of the conductor 646.

The conductor 646 illustratively comprises spokes, and may besubstantially identical in shape to the electrical contact 602 andelectrode lead lines 608. This is merely illustrative as the conductor646 may have shapes of electrodes 204, 304 described in connection withFIGS. 2A-4B. Regardless of the selected shape of the conductor 646,there must be overlap of the contacting portion 610, which isillustratively ring-shaped, and the electrical lead layer 646.

Finally, the apparatus 600 comprises an adhesive layer 612 that affixesthe apparatus to the body and a release liner 649 (not shown in FIGS.1A-5B) that is removed so the apparatus 600 can be applied to the body.

In operation, the apparatus 600 is adhered to the body by adhesivedisposed over the electrode 604 making physical contact to the body viathe adhesive layer 612. The electrode lead lines 608 provide anelectrical connection between the electrode 604 and the electricalcontact 602, which is illustratively a snap contact that connects tolead from a measurement or monitoring device (not shown).

Beneficially, the layer 606 is a breathable material wicks moisture fromthe region where the electrode 604 makes contact with the body andsubstantially reduces or prevents collection of moisture in the regionwhere the electrode 104 makes contact with the body (i.e., between theelectrode 604 and the body).

In certain representative embodiments, the layer 606 and the optionalfoam layer 644 comprise an open cell foam material that is breathableand beneficially exhibits moisture removal from the region where theelectrode makes contact with the body. Notably, open cell foam is asynthetic foam in which all air pockets are not completely enclosed andhave a ‘cobweb’ or ‘lattice’ structure appearance. The open cell foamcontemplated for use as the layer 606 and the optional foam layer 644are soft and flexible compared to known materials used in wound care.Selected open cell foam materials contemplated for use as the layer 606(and optional foam layer 644) are not substantially moisture (e.g.,water, sweat) resistant allowing water to flow between the air pockets,and ultimately and beneficially out of the region where the electrode104 makes contact with the body. Illustratively, open cell foam fromYulex® Incorporated of Chandler, Ariz. USA, such as Yulex® OC foam, maybe used for the layer 106. Finally, the optional foam layer 644 may beforegone because it is not necessary to provide an electrode lead line(e.g., 108) over an edge of the foam layer.

FIG. 6B is top view of an electrode for use in an apparatus for makingelectrical connections in electrophysiological measurements andmonitoring according to a representative embodiment. Various aspects anddetails of the presently described representative embodiments are commonto those described above in connection with FIGS. 1A-5B, and may not berepeated to avoid obscuring the presently described representativeembodiments.

FIG. 6B is top view of the apparatus 600 shown in FIG. 6A for makingelectrical connections in electrophysiological measurements andmonitoring according to a representative embodiment. Various aspects anddetails of the presently described representative embodiments are commonto those described above in connection with FIG. 1A, and may not berepeated to avoid obscuring the presently described representativeembodiments.

The spoke-like structure of the electrode lead lines 608 increase thesurface area of layer 606 that is exposed to the ambient. Moreover, asnoted above, the electrode 604 may be spoke-like or may have the shapeof electrodes 204, 304, 404 as shown in FIGS. 2A-4B, or may have thesame shape as the electrode lead lines 608 and electrical contact 602.This structure also fosters improved mobility of the electrode 604 onthe side that contacts the body. Specifically, the electrode 604 areelastic and follow the movements of the skin. By providing a comparativereduction in the area of connection of the electrode 604 (compared, forexample, to the electrode 304 of FIG. 3A or electrode 104 of FIG. 1B),the electrode structure 620 is more pliable. This increase in pliabilityallows the electrode structure 620 to move more freely with movement ofthe anatomical part of the body to which it is attached, resulting in amore comfortable connection with a reduction in its becoming unattachedfrom the body. So, in addition to providing an improvement in moistureremoval, the grooves and openings described below further improve thelong-term performance of the electrode structures of variousrepresentative embodiments.

Although a variety of apparatuses for making electrical connections tomeasurement and monitoring devices in electrophysiological measurementsand monitoring have been described with reference to several exemplaryembodiments, it is understood that the words that have been used arewords of description and illustration, rather than words of limitation.Changes may be made within the purview of the appended claims, aspresently stated and as amended, without departing from the scope andspirit of interventional procedure optimization in its aspects.

The illustrations of the embodiments described herein are intended toprovide a general understanding of the structure of the variousembodiments. The illustrations are not intended to serve as a completedescription of all of the elements and features of the disclosuredescribed herein. Many other embodiments may be apparent to those ofskill in the art upon reviewing the disclosure. Other embodiments may beutilized and derived from the disclosure, such that structural andlogical substitutions and changes may be made without departing from thescope of the disclosure. Additionally, the illustrations are merelyrepresentational and may not be drawn to scale. Certain proportionswithin the illustrations may be exaggerated, while other proportions maybe minimized. Accordingly, the disclosure and the figures are to beregarded as illustrative rather than restrictive.

Although specific embodiments have been illustrated and describedherein, it should be appreciated that any subsequent arrangementdesigned to achieve the same or similar purpose may be substituted forthe specific embodiments shown. This disclosure is intended to cover anyand all subsequent adaptations or variations of various embodiments.Combinations of the above embodiments, and other embodiments notspecifically described herein, will be apparent to those of skill in theart upon reviewing the description.

The Abstract of the Disclosure is provided to comply with 37 C.F.R. §1.72(b) and is submitted with the understanding that it will not be usedto interpret or limit the scope or meaning of the claims. In addition,in the foregoing Detailed Description, various features may be groupedtogether or described in a single embodiment for the purpose ofstreamlining the disclosure. This disclosure is not to be interpreted asreflecting an intention that the claimed embodiments require morefeatures than are expressly recited in each claim. Rather, as thefollowing claims reflect, inventive subject matter may be directed toless than all of the features of any of the disclosed embodiments. Thus,the following claims are incorporated into the Detailed Description,with each claim standing on its own as defining separately claimedsubject matter.

The preceding description of the disclosed embodiments is provided toenable any person skilled in the art to practice the concepts describedin the present disclosure. As such, the above disclosed subject matteris to be considered illustrative, and not restrictive, and the appendedclaims are intended to cover all such modifications, enhancements, andother embodiments which fall within the true spirit and scope of thepresent disclosure. Thus, to the maximum extent allowed by law, thescope of the present disclosure is to be determined by the broadestpermissible interpretation of the following claims and their equivalentsand shall not be restricted or limited by the foregoing detaileddescription.

1. An apparatus for making electrical connections inelectrophysiological measurements and monitoring, the apparatuscomprising: a first side comprising an electrical contact; a second sideopposing the first side comprising an electrode disposed over the secondside; a layer disposed between the first side and the second side,wherein the layer is adapted to remove moisture from a region around theelectrode; and an electrode line in electrical contact with theelectrode, the electrode line being disposed over the layer on the firstside and extending over the layer on the second side, wherein theelectrode line is electrically connected to the electrical contact. 2.The apparatus of claim 1, wherein the layer on the second side is incontact with skin.
 3. The apparatus of claim 2, wherein openings existin the electrode, the openings being adapted to allow the layer tocontact the skin.
 4. The apparatus of claim 2, wherein an area of thelayer in contact with the skin has a greater magnitude of the electrodein contact with the skin.
 5. The apparatus of claim 2, wherein the layercomprises a biocompatible material.
 6. The apparatus of claim 2, whereinthe layer comprises an open cell foam material.
 7. An apparatus formaking electrical connections in electrophysiological measurements andmonitoring, the apparatus comprising: a first side comprising anelectrical contact; and a second side opposing the first side comprisingan electrode disposed over the second side, wherein the electrodecomprises a groove adapted to remove moisture from a region around theelectrode.
 8. The apparatus of claim 7, wherein the second side is incontact with skin.
 9. The apparatus of claim 7, wherein the groove isone of a plurality of grooves.
 10. The apparatus of claim 9, wherein theplurality of grooves is in a pattern to facilitate removing of themoisture.
 11. The apparatus of claim 8, wherein the electrical contactcomprises an area and the groove extends past a boundary of the area.12. The apparatus of claim 7, wherein the groove provides a capillaryaction.
 13. The apparatus of claim 7, wherein the groove comprises avenus valve.
 14. An apparatus for making electrical connections inelectrophysiological measurements and monitoring, the apparatuscomprising: a first side comprising an electrical contact; a second sideopposing the first side comprising an electrode disposed over the secondside; a layer comprising a gap and being disposed between the first sideand the second side, wherein the gap is adapted to remove moisture froma region beneath the electrical contact; and a plurality of electricallyconductive spokes extending radially from an outer boundary of theelectrical contact.
 15. The apparatus of claim 14, wherein the pluralityof electrically conductive spokes provide electrical connection to theelectrode on the second side.
 16. The apparatus of claim 14, wherein thelayer on the second side is in contact with skin.
 17. The apparatus ofclaim 14, wherein the layer comprises a biocompatible material.
 18. Theapparatus of claim 14, wherein the layer comprises an open cell foammaterial.